Portable disposable re-usable culture device for rapid diagnosis of infectious agents

ABSTRACT

The present invention is directed to compositions, tools, methods and devices to culture microorganisms and, in particular, to compositions, tools, methods and devices for the detection of microorganisms in biological samples.

REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/148,943, filed Apr. 17, 2015, and 62/270,754, filed Dec. 22, 2015,both entitled “Portable Disposable Re-Usable Culture Device for RapidDiagnosis of Infectious Agents,” and both hereby specifically andentirely incorporated by reference.

BACKGROUND

1. Field of the Invention

The present invention is directed to compositions, tool, methods anddevices to culture microorganisms and, in particular, to compositions,tools, methods and devices for the detection of microorganisms inbiological samples.

2. Description of the Background

Microorganisms such as bacteria, virus, parasites and more can belife-threatening infections when detected in a patient. Often, theability to save a life depends on the prompt identification of theinfectious agent so that appropriate antimicrobial therapy can begin.Certain infections can be detected and identified directly from ananalysis of a biological sample, whereas others require culturing of thesample to increase the number of microorganisms to a detectable level.With regard to the later, incubators have proven to be an invaluabletool. Very simply, the biological sample is placed in an incubator andallowed to proliferate under conditions that promote growth. After aperiod of time the microorganism, if present, becomes detectable.

Many different incubators have been developed and are availablecommercially (e.g., see U.S. Pat. No. 3,796,639). The key features of anincubator include the ability to properly culture the sample and tomaintain containment of the sample. A need exists to reduce the timebetween collection of samples from a patient or source andidentification of the infection so that administration of the correctantimicrobial therapy can either begin or be avoided.

SUMMARY OF THE INVENTION

The present invention overcomes the problems and disadvantagesassociated with current strategies and designs and provides new tools,compositions, methods and devices for culturing and detectingmicroorganisms.

One embodiment of the invention is directed to a disposable and/orreusable kit for detection of a microorganism or group of microorganismsin a biological sample. The kit comprises a culture device comprising anincubator and an environmental chamber into which is placed theincubator or the incubator is attached, culture medium contained withinthe incubator that promotes the proliferation or stabilization of themicroorganism or group of microorganisms, and a collection tool forobtaining the biological sample and directing delivery of the biologicalsample to the incubator.

In a preferred embodiment, the collection tool is a flocked swab.Preferably, the culture medium comprises one or more ingredients whichpromote the proliferation or stabilization of the microorganism or groupof microorganisms. The culture medium preferably comprises ingredientsthat inhibit proliferation or stabilization of one or moremicroorganisms that are not the microorganism or group of microorganismsto be detected. Preferably, environmental chamber contains one or moredevices that control the environment of the incubator. In a preferredembodiment, the one or more devices comprise a heating element, acooling element, a pH control element, a humidity control element, anoxygen control element, a carbon dioxide control element, a vibrator, ora light control element. Preferably, the environmental chamber containsa USB port that connects the one or more devices to an externalprocesser containing software that controls the operation of the one ormore elements, or the environmental chamber contains a microprocessorthat contains software to control the one or more environmental controlelements.

Preferably the culture device is comprised of plastic. In a preferredembodiment, the culture device further comprises a micro-fluidic device,wherein the micro-fluidic device allows for inclusion of a lateral flowassay or device incorporated into the incubator for testing thebiological sample upon completion of incubation with or without anoptical reader to read or report a result.

Another embodiment of the invention is directed to a method of detectinga microorganism or group of microorganisms. The method comprises thesteps of obtaining a biological sample with or without a collectiontool, placing the biological sample into an incubator containing culturemedium for the proliferation and or stabilization of the microorganism,sealing the incubator closed, placing the closed incubator within orattached to an environmental chamber, allowing the microorganism orgroup of microorganisms to proliferate and or stabilize in the incubatorfor a period of time, and assessing proliferation and or stabilizationof the microorganism or group of microorganisms to determine thepresence or absence of the microorganism or group of microorganisms inthe biological sample.

Preferably, the biological sample is self-obtained. In a preferredembodiment, the environmental chamber contains one or more environmentalcontrol elements. Preferably, the one or more environmental controlelements comprise a heating element, a cooling element, a pH controlelement, a humidity control element, an oxygen control element, a carbondioxide control element, a vibrator, or a light control element.Preferably, the environmental chamber contains a USB port that connectsthe one or more environmental control elements to an external processercontaining software that controls the operation of the one or moreenvironmental control elements and/or the environmental chamber containsa microprocessor that contains software to control the one or moreenvironmental control elements. The method preferably further comprisesdetermining a quantitative or relative concentration of themicroorganism or group of microorganisms.

In a preferred embodiment, the period of time is from 1 hour to 7 days.Preferably, assessing comprising removing a sample from inside theincubator and determining the presence or absence of the microorganism.Preferably, assessing comprising performing a visual or chemicalassessment, immunoassay, lateral flow assay, enzyme linked immunoassay,an immunochemistry assay, a polymerase chain reaction, a latexagglutination, other microbiologic assay or a combination thereof. In apreferred embodiment, assessing comprising insertion of a device toperform an analysis. The analysis preferably comprises a visualanalysis, a chemical analysis, an immunoassay, a lateral flow assay, anenzyme linked immunoassay, an immunochemistry assay, a polymerase chainreaction, a latex agglutination, other microbiologic assay or acombination thereof.

Preferably, the analysis is a visual analysis and the method furthercomprises determining at least one of turbidity and color change with anoptical reader. The method preferably further comprises transmitting theassessment electronically to a physician, health care worker, aprofessional, an expert, a patient or another individual, or to apatient's medical or health care record. Preferably, the transmitting isaccomplished by a WiFi.

Another embodiment of the invention is directed to an incubator. Theincubator comprises a base, a lid adapted to be coupled to the base, asample gathering device coupled to the lid, a multi-chamber cavitywithin the base, and a seal adapted to prevent fluid from escaping afirst chamber of the multi-chamber cavity and entering a second chamberof the multi-chamber cavity.

Preferably, the sample gathering device is a flocked swab. In apreferred embodiment, the flocked swab is coupled to the lid by a rod.The incubator preferable further comprises a sample conditioning device.Preferably, the sample conditioning device is one of a fluid agitator, aheating device, a cooling device, a moisture removal device, a moistureadding device, a pH control element, a humidity control element, anoxygen control element, a carbon dioxide control element, or a lightcontrol element. In a preferred embodiment, the sample conditioningdevice is housed in a third chamber of the multi-chamber cavity and thethird chamber is sealed from the first and second chambers.

Preferably, the incubator further comprises a switch adapted to activatethe sample conditioning device. Preferably, the seal is a penetrablemembrane adapted to be pierced by the sample gathering device. In apreferred embodiment the base and the lid are maintained in a firstposition prior to sample gathering and are maintained in a secondposition after sample gathering. Preferably, in the first position theswab is maintained outside the first chamber and in the second positionthe swab is maintained within the first chamber.

Another embodiment of the invention is directed to a sample evaluationsystem. The system comprises an incubator comprising: a base, a lidadapted to be coupled to the base, a sample gathering device coupled tothe lid, a multi-chamber cavity within the base, and a seal adapted toprevent fluid from escaping a first chamber of the multi-chamber cavityand entering a second chamber of the multi-chamber cavity; and a sampleconditioning fluid housed within the first chamber.

In a preferred embodiment, the sample gathering device is a flockedswab. Preferably, the flocked swab is coupled to the lid by a rod. Theincubator preferably further comprises a sample conditioning device.Preferably, the sample conditioning device is one of a fluid agitator, aheating device, a cooling device, a moisture removal device, a moistureadding device, a pH control element, a humidity control element, anoxygen control element, a carbon dioxide control element, or a lightcontrol element. The sample conditioning device is preferably housed ina third chamber of the multi-chamber cavity and the third chamber issealed from the first and second chambers. Preferably, the incubatorfurther comprises a switch adapted to activate the sample conditioningdevice. Preferably, the seal is a penetrable membrane adapted to bepierced by the sample gathering device.

Preferably, the base and the lid are maintained in a first positionprior to sample gathering and are maintained in a second position aftersample gathering. In a preferred embodiment, in the first position, theswab is maintained outside the first chamber and, in the secondposition, the swab is maintained within the first chamber so that thesample comes into contact with the sample conditioning fluid.Preferably, the sample is a microorganism or group of microorganisms andthe sample conditioning fluid is a culture medium that promotes theproliferation or stabilization of the microorganism or group ofmicroorganisms.

Another embodiment of the invention is directed to an incubator. Theincubator comprises a base and a sample assembly contained within thebase. The sample assembly comprises a lid, a sample gathering devicecoupled to the lid, and an ampule. The sample assembly is positionablebetween a sample gathering position and a sample incubating position.

Preferably, the sample gathering device is a flocked swab. The flockedswab is preferably coupled to the lid by a rod. In a preferredembodiment, the incubator further comprises a sample conditioningdevice. Preferably, the sample conditioning device is one of a fluidagitator, a heating device, a cooling device, a moisture removal device,a moisture adding device, a pH control element, a humidity controlelement, an oxygen control element, a carbon dioxide control element, ora light control element.

In a preferred embodiment, the sample gathering device is maintainedoutside the ampule in the sample gathering position and is forced intothe ampule in the sample incubating position. The incubator preferablyfurther comprises a penetrable membrane separating contents of theampule from the sample gathering device, wherein the penetrable membraneadapted to be pierced by the sample gathering device. The incubatorpreferably further comprises a switch adapted to activate the sampleconditioning device. Preferably, the incubator is adapted to collect,process, transport, and stabilize a sample for use in biomarkerdeterminations or cancer tissue testing. The incubator is preferablyadapted to collect, incubate, and transport a biological sample.

Another embodiment of the invention is directed to a sample evaluationsystem. The system comprises an incubator comprising a base and a sampleassembly contained within the base, and a sample conditioning mediumhoused within an ampule. The sample assembly comprises a lid, a samplegathering device coupled to the lid and the ampule. The sample assemblyis positionable between a sample gathering position and a sampleincubating position.

Preferably, the sample gathering device is a flocked swab. In apreferred embodiment, the flocked swab is coupled to the lid by a rod.Preferably, the incubator further comprises a sample conditioningdevice. The sample conditioning device is preferably one of a fluidagitator, a heating device, a cooling device, a moisture removal device,a moisture adding device, a pH control element, a humidity controlelement, an oxygen control element, a carbon dioxide control element, ora light control element. Preferably, the sample gathering device ismaintained outside the ampule in the sample gathering position and isforced into the ampule in the sample incubating position. The systempreferably further comprises a penetrable membrane separating contentsof the ampule from the sample gathering device, wherein the penetrablemembrane adapted to be pierced by the sample gathering device.

The system preferably further comprises a switch adapted to activate thesample conditioning device. Preferably, the sample is a microorganism orgroup of microorganisms and the sample conditioning fluid is a culturemedium that promotes the proliferation or stabilization of themicroorganism or group of microorganisms. The incubator is preferablyadapted to collect, process, transport, and stabilize the sample for usein biomarker determinations or cancer tissue testing.

Other embodiments and advantages of the invention are set forth in partin the description, which follows, and in part, may be obvious from thisdescription, or may be learned from the practice of the invention.

DESCRIPTION OF THE FIGURES

FIG. 1 One embodiment of the device of the invention.

FIGS. 2A-D Views of one embodiment of an incubator of the invention.

FIG. 3 Another embodiment of an incubator of the invention.

FIG. 4 Another embodiment of an incubator of the invention.

FIG. 5 Another embodiment of an incubator of the invention.

FIG. 6 Another embodiment of an incubator of the invention.

FIGS. 7A-B Views of another embodiment of an incubator of the invention.

FIGS. 8A-B Views of an embodiment of a swab of the invention.

FIGS. 9A-C Views of an embodiment of the swab prior to penetrating theampule.

FIGS. 10A-C Views of an embodiment of the swab after penetrating theampule.

DESCRIPTION OF THE INVENTION

Culture devices are well known and commercially available in manydifferent forms. Culture devices are configured to control and maintaina suitable environment for the proliferation of desired organismsfollowed by subsequent analysis and detection. Culture devices aretypically bulky, expensive to build, complicated to operate; requiringpersonnel with specialized training, and require cleaning followed bysterilization before re-use.

Culture devices as disclosed herein have been developed that areportable, inexpensive to build and operate, as compared to conventionaldevices, and disposable. Culture devices of the invention are adapted totransport samples and comprise a disposable and optionally hand-heldincubator containing growth medium, into which is placed a biologicalsample, and an environmental chamber which may be re-usable into whichis placed the incubator or the incubator is fixed into the environmentalchamber. Preferably the incubator, which is disposable, is a containerthat comprises growth medium that encourages the growth of themicroorganism and/or host organisms which is required for proliferationor stabilization of the microorganism of interest. Preferably, thedevice preserves the sample. For example, the device may contain amedium that prevents the sample from decomposing, breaking down,oxidizing, or otherwise degrading. The container may be any geometricshape such as, for example, a cube or preferably a cylinder. Theenvironmental chamber, which may be disposable or reusable, controlsand/or maintains the environmental conditions of the incubator necessaryfor the growth and propagation and or stabilization of a specifiedmicroorganism or group of microorganisms. Devices of the invention canbe designed to promote the growth and or stabilization of one or morespecific microorganisms or classes of microorganisms including, forexample, bacteria, viruses, fungi, parasites and/or other infectiousagents (collectively “microorganisms”). The culture devices of theinvention provide and maintain temperatures within a range required foroptimum growth and or stabilization of the specified microorganism orgroup of microorganism and/or for optimum growth and or stabilization ofhost organisms such as cells or other host organisms that are infectedwith the microorganism or group of microorganisms to be detected. Theunique design and composition of the device permits use by trainedprofessionals and by persons with minimum or no training and can includeinstructions for operation by lay persons such as the patient. Thedevice allows for the easy collection of a biological sample in asterile, semi-sterile, or non-sterile fashion which is easily andsecurely placed into an incubator portion, containing growth media andsecurely closed. In other embodiments, the sample may be a non-microbialor non-biological sample. The incubator is placed into an environmentalcontrol chamber or may be already fixed into the environmental controlchamber that may include heating and/or cooling elements, pH controlelement, oxygen control element, carbon dioxide control element, fluidagitation element, ambient temperature monitor element, light controlelement, and/or a desired humidity control element. The device can beconnected through a USB or other information transfer circuit to bemaintained and/or controlled through a processor and/or theenvironmental chamber contains a microprocessor that contains softwareto control the one or more environmental control elements. The processoris pre-programmed to operate the environmental chamber underpredetermined conditions of, for example, temperatures, humidity, pH,oxygen concentration or other environmental parameter. The device of theinvention operates independently for a period of time and without anyneed for further maintenance, whether constant or occasional. After apre-specified period of time, as determined by the microorganism orgroup of microorganisms to be detected and preferably at ambienttemperatures, the entire device is either brought to a physician, ahealth care worker, a professional or other expert with regard to theanalysis to be performed, to determine the presence of absence of themicroorganism in the biological sample or tested by the patient, and ineither case, the results may be transmitted to the physician, healthcare worker, a professional or other expert or the hospital or clinicmedical record of the patient electronically. For example, the resultsmay be transmitted by wired or wireless (e.g. WiFi, Bluetooth)communication protocols.

One embodiment of the devices of the invention comprises anenvironmental chamber containing an incubator in the form of areceptacle of a size that preferably is between about 0.5 ml and about10 ml of volume, more preferably from about 1-5 ml, and more preferablyfrom about 1-3 ml. The receptacle size may be any three-dimensionalgeometric structure such as a cube, a tube or cylinder. The receptacleis designed so as to promote the ease of administration or inoculationof a sample such as, for example, a biological, agricultural orenvironmental sample. Preferably the container is the minimum volumenecessary to promote growth of the microorganism to detectable levels.An inoculation tool may comprise, for example, a swab, a stick, a brush,a cotton ball, a sponge, a needle, a pipette or another samplecollection mechanism that allows for collection of the sample or directadministration of the sample (e.g. oral secretions or spit) suspected ofcontaining the microorganism to be detected. Preferably, the collectiontool is a flocked swab.

A preferred biological sample is a sample that can be obtained by aperson without assistance. The person can be a patient, a patient'shelper, a medical professional, a layperson, or another person.Preferably the person is without professional training in the art ofthis sample collection. For example, preferred samples are swabsobtained from the mouth (e.g., oral cavity, throat), nasal passages,eyes, ears, mammary discharge, anus, vagina, cervix, urine, stool, skin,hair, finger stick blood or other means of obtaining blood, or finger ortoe nails. Preferred environmental samples include samples obtained fromsoils, bodies or water, animals, foodstuffs, and any biomass.

The device of the invention is useful for the detection ofmicroorganisms and preferable viruses such as, for example, influenzavirus, adenovirus, coronavirus, rhinovirus, enteric viruses, herpesvirus, papilloma viruses, rotavirus, vesicular viruses, or many otherviruses, bacteria such as, for example, mycobacteria (e.g.,Mycobacterium tuberculosis), mycoplasma (e.g. Ureaplasma parvum,Ureaplasma urealyticum), salmonella, streptococcus, bacillus,pseudomonas or many other bacteria, fungal microorganisms such as, forexample, Cryptococci, aspergillus and candida, or many other fungalmicroorganisms, and/or parasites such as, for example, endoparasites,protozoan, and helminth, or many other parasite microorganisms.

The device of the invention may optionally contain an amount of a hostorganism necessary for proliferation and/or detection of themicroorganism or group of microorganisms of interest. Host organismsinclude, for example, feeder layers of eukaryotic or prokaryotic cells,cells that produce growth factors that promote microorganismproliferation, stabilization, and/or inhibit proliferation of othermicroorganisms or organisms. Typical feeder layers comprise eukaryoticor prokaryotic cells for the detection of microorganisms of interest.

The device preferably contains a predetermined amount of a growthmedium. Preferably, the container is a small cylinder with a volume offrom 0.5-10 cc that holds from 0.5-10 ml of culture medium. However, thecylinder can have another volume, for example the cylinder may be ableto hold up to 50 ml, up to 100 ml, or up to 250 ml, or larger.Additionally, the cylinder may be a commonly used culture vial. Manydifferent growth media are commercially available or can be preparedfrom the known growth requirements of a particular microorganism orgroup of microorganisms. The medium is preferably a fluid or a gel, andmay be a solid, a liquid or a semi-solid material, selected to promotethe growth and or stabilization of certain microorganism or group ofmicroorganisms suspected to be within the sample and/or the hostorganisms. Also preferably, the medium contains ingredients that inhibitthe growth of other microorganisms and/or organisms that do not enhancethe detection or the microorganism or group of microorganisms ofinterest. Preferably, the medium allows for the concentration andpreservation of the sample so that diagnostic procedures can be appliedto diagnose the presence or absence of the specific microorganism orgroup of microorganisms after the incubation period. Preferably themedia of the container allows for ease of placement of the sample viaswab, needle, pipette or other inoculation tool or directly without acollection tool. Growth medium and conditions that permit proliferationof many microorganisms is well known and commercially available to thoseskilled in the art (e.g. see, LifeTechnologies, Grand Island, N.Y.;Medical Microbiology, 26th edition, Jawetz, Melnick, & Adelberg'sMedical Microbiology; Clinical Microbiology, 11^(th) edition Jorgensenand Pfaller's, Manual of Clinical Microbiology).

In some embodiments, the device is used for the collection, initialprocessing, transport, and temperature stabilization of samples for usein biomarker determinations or cancer tissue testing. Preferably thetemperature stabilization includes incubation and heating or cooling tomaintain a specific temperature. For example, the temperature may beambient temperature (i.e. 20 to 30° C.), a refrigerated temperature(i.e. 2 to 8° C.), or a frozen temperature (i.e. at or less than 20°C.). The sample may be blood, body tissues, other body fluids, tumors,or another biological sample.

Also preferable, the container allows for ease of withdrawal of a sampleafter incubation to allow detection of the microorganism, for example,via a swab, needle or a pipette, and thereafter interface with adiagnostic device such as, for example, a lateral flow assay, ELISA,PCR, or like or combinations of these. Alternatively, the incubator doesnot require withdrawal of a sample after incubation but instead containsculture medium that also comprises a chemical that provides for visualor chemical detection of microorganism growth. The chemical may be aspecific enzyme that reacts with a component, such as a specificbiochemical, enzyme, or sequence (e.g., nucleic acid or amino acid)produced by the cultured microorganism. Alternatively, the incubatordoes not require withdrawal of a sample after incubation but insteadconnects directly to a device or allows insertion or incorporation ofthe device into the incubator to perform the analysis such as, forexample immunoassay (e.g. a lateral flow assay, or an enzyme linkedimmunoassay, or an immunochemistry assay), a polymerase chain reactionassay, or a visual reading (e.g when using chromogenic media by directvisualization of the media color or via optical reader) or microbiologicassay, or the like or a combination of these. One advantage of having avisual or chemical detection or direct connection to a device orinsertion of the test into the device is that the container does notneed to be opened and can be disposed of safely and securely withoutgenerating any additional biological waste.

Preferably the devices of the invention include a temperature controlmechanism such as, for example, a heater or cooler that may bemaintained at a set temperature and/or activated and/or deactivated by asensor that provides temperature information regarding the interior ofthe container. Suitable temperature control devices are commerciallyavailable and include, but are not limited to probe heaters,temperature-control heaters, and coolers. Storage temperature can bepreset on heaters or temperature-control devices, or contained in themedia container that is inserted into the device or on a microchipcontained in the device. Preferably, the device includes an internaltemperature sensor in or on the incubator to monitor and adjust theincubator's temperature is maintained at the set levels.

Preferably, the container is designed to promote the ease of use ofdiagnostic assays that can be applied after growth of the specificmicroorganism or group of microorganisms. Suitable assays include, butare not limited to, visual or chemical assessment assays, immunoassays(e.g. a lateral flow assay, or an enzyme linked immunoassay, or animmunochemistry assay), a polymerase chain reaction assay, ormicrobiologic assay, or the like or a combination of these.

Samples to be introduced into the devices of the invention that aresuspected to contain microorganisms to be cultured and detected may beobtained from sources where infectious agents are found. For example,biological samples may be obtained from humans or other animals,environmental samples may be obtained from the land or water, or otherregions such as man-made waste sites and the like. Biological samplesinclude, but are not limited to, respiratory including nasal, oral andtracheal, intestinal including gastric and stool, genitourinaryincluding vaginal, cervical, prostate, and urine, skin includingabscesses and wounds, and other body fluids including blood,cerebrospinal spinal fluid, peritoneal fluid, and pleural fluid, orother sources.

Preferably the devices of the invention are cultured for a period oftime during which, no maintenance is required. Preferably, the period oftime is about 14 days. However, the period of time can be less (i.e. 1day, 3 days, 7 days, or 10 days) or more (i.e. 20 days, 30 days, or 60days). The devise is either maintained independently or coupled to acontrol mechanism through, for example, a USB port. The USB port allowsfor an external processor to control one or more sensors and/or controlelements placed within the environmental chamber to raise or lower thetemperature, pH, humidity, light exposure, oxygen concentration, carbondioxide concentration or another environmental parameter of the chamberand/or the incubator or environmental conditions outside the device(e.g. ambient temperature), and/or the environmental chamber contains amicroprocessor that contains software to control the one or moreenvironmental control elements. Additionally, the USB connection mayallow the sample to be incubated for extended periods of time, forexample 2 weeks, 4 weeks, 2 months, or 6 months by supplying externalpower to the device. In another embodiment, the device may be able to beplugged into a wall outlet to be powered. Preferable, the incubator canbe maintained, either independently or under control of an automatedsystem, for a period of time such as, for example, from 1 hour to 14days, more preferable from 2 hours to 7 days, and more preferable from 4hours to 3 days. Preferably, the incubator includes a timer (either aphysical timer or a software based timer) that measures the incubationperiod and outputs a signal indicating the amount of time that thesample has been incubated. For example, the timer may use one light toindicate that the sample is being incubated and another light toindicate that the incubation is complete. The incubator may additionallyhave an optical reader. The optical reader may be adapted to determineturbidity in the fluids (for example, to determine if the sample hassufficiently been incubated) or color changes within the fluids (forexample, to determine if specific bacteria is present, chromogenic mediamay be used).

The devices of the invention preferably are compatible with commerciallyavailable detection kits (e.g. those being developed by Vax-Immune forrapid diagnosis of various microorganisms or group of microorganisms),with an operating temperature that can be set for one or moretemperatures and/or temperature ranges (e.g., about 35° F. to about 98°F. (2° C. to 37° C.). Preferably the device is powered via a USBconnector, a battery, or an external power source (e.g., at 110/115 v or220/240 v). Preferably the temperature set point is from 35° C. to 37°C. (+/−1° C. or 2° C.) for bacterial, fungal or viral growth, and 2° C.to 37° C. (+/−1° C. or 2° C.) for media storage with a microprocessor tomonitor and control temperature and time. Also preferably the device isportable and of a size that fits in the palm of a hand with an on-offswitch to engage for bacterial, viral, fungal or other microbial growth.The switch may be located on the lid or another location on or withinthe device.

The device of the invention provides a simplified collection device andincubator that can be hand carried from place to place. The portabledevice of the invention preferably comprises a chamber having an opentop or side for receiving or contains a closed receptacle containing thebiological sample and growth medium. A lid is clamped to the top of thechamber for closing the same, the chamber having a seal for engaging thelower surface of the lid near its outer periphery. Optionally, thechamber is fitted with a conduit in fluid communication with theexterior to carry one or more fluids or gases or other elements intoand/or out of the chamber. The conduit may have terminal ends withvalves for controlling the flow of fluid or gases or elements throughthe conduit.

The incubator can be placed into or is built into the chamber having atop or side wall provided with an opening for receiving the incubator.The chamber may have heating coils on one or more of its side or bottomwalls or on one or more side or bottom walls of the incubator forheating the contents of the incubator. In an alternative embodiment, thechamber is a cylinder extending downwardly from the top wall forreceiving or containing a cylindrical incubator, the cylinder being ofheat conductive material and provided with a heater coil carried by andsurrounding its outer surface. The latter embodiment provides betterheat distribution within the incubator and eliminates any electricalshock hazards which might arise by a person inserting a hand into thehousing. The portable incubator of the invention combines versatility,safety and economy with absolute integrity in culture or microorganismgrowth or sample stabilization.

Another embodiment of the invention is directed to a kit comprising aculture devise of the invention comprised of an incubator containing adesired culture medium, and an environmental chamber, in addition to asample collection device, a sample withdrawal device and optionally adetection mechanism. Preferred sample collection and/or samplewithdrawal devices include swabs, needles, pipettes and otherinoculation and/or collection devices but in other options, samples canbe placed directly into the chamber. Preferable, the sample collectiondevice is designed to interact and deposit sample into the containerwith sterility or near sterility, in other words there is nocontamination of the sample attributable to the collection or depositionof the sample into the device of the invention.

Another embodiment of the invention comprises methods of collection,incubating and detecting a microorganism or group of microorganisms ofthe sample. Preferable, sample is collected with a sample collectiondevice that is designed to avoid contact with anything but the samplesource and the culture container. The culture container contains mediaprepared to promote culturing of the microorganisms of interest and/orinhibit microorganisms of no interest. Also preferable the sample isincubated on or within the media after which, a sample is removed fromthe container for analysis or the analytic device is inserted into thecontainer. Preferably the sample removed or tested is analyzed for thepresence and/or absence and or concentration of the microorganism orgroup of microorganisms of interest such as, for example by, visual orchemical assessment, immunoassay (e.g. a lateral flow assay, or anenzyme linked immunoassay, or an immunochemistry assay, or a latexagglutination), a polymerase chain reaction, or the like or acombination of these. Alternatively, the incubator does not requirewithdrawal of a sample after incubation but instead connects directly toa device that performs the analysis such as, visual or chemicalassessment, immunoassay (e.g. a lateral flow assay or an enzyme linkedimmunoassay, or an immunochemistry assay, or a latex agglutination), apolymerase chain reaction, other microbiologic assay, or the like or acombination of these.

After analysis by a physician, health care worker or other professionalor expert in the microorganism of interest, or the patient or individualwho collected the sample, the device can be safely disposed asbiological waste. Preferably, no additional biological waste isgenerated during the analysis.

While the invention is described for use with obtaining, culturing, andanalyzing microorganisms, the invention can be used for other sampletaking of non-microbial or non-biological samples. For example, thedevice may be used for collecting DNA. The sample may be saliva oranother bodily fluid or tissue (e.g. tumor sample) and the medium may bea substance used to prevent the breakdown of the DNA, etc. As anotherexample, the device may be used for testing water quality, soilcomposition, air quality, or other environmental considerations. Thesample may be the dirt, water, rocks, air or other substance and themedium may be a substance used to breakdown the sample.

The following examples illustrate embodiments of the invention, butshould not be viewed as limiting the scope of the invention.

EXAMPLES Example 1

One embodiment of the invention is depicted in FIG. 1. Shown is acylindrical container enclosed within a square chamber. The squarechamber holds a heating element wrapped about the cylinder and a USBconnection connectable to a processor outside of the container. Theprocessor contains software designed to control the heating and orcooling element and optionally the environment within the container(e.g., humidity, pH, UV or visible light, oxygen concentration, carbondioxide concentration). Also shown is a capped cylindrical containerthat contains a culture medium designed to promote the proliferation andor stabilization of a desired microorganism or group of microorganisms.Also depicted is a sample collection device in the form of a swabembedded within the culture medium. The swab can be used to collect asample from a desired biological source and the sample placed within oron top of the culture medium, as shown or a sample can be directlyplaced into the culture medium. The cap is then secured as depictedwhich provides sterile conditions for proliferation and or stabilizationof microorganisms from the collection swab. The receptacle can be easilyplaced within the heated chamber and the chamber closed with a securelatch.

Example 2

Twenty women are tested conventionally for the presence of vaginalUreaplasma urealyticum (one of seven species of Ureaplasma) at 38 weeksof pregnancy using a commercially available kit. Tests are performedwith a Duplica^(RealTime) Ureaplasma urealyticum detection kit(commercially available from EuroClone S.P.A., Pero, Italy). Only tentests indicate the positive presence of Ureaplasma urealyticum. Twentydevices as described in Example 1 are distributed to the same twentywomen at 39.5 weeks of pregnancy. Each woman self-collects a sample ofvaginal fluid with a flocked swab and places the entire swab into theincubator. The incubators are sealed closed and placed with twentyenvironmental chambers each of which is maintained at 37° C. for thefinal week of the pregnancy. At the end of 40 weeks, each womandelivered a healthy infant and the incubators were checked for thepresence of Ureaplasma urealyticum. Of the ten women who tested positivefor ureaplasma in the conventional test, only five showed the presenceof Ureaplasma urealyticum in their respective incubators. Of the tenwomen who tested negative for Ureaplasma urealyticum in the conventionaltest, one showed the positive presence of Ureaplasma urealyticum in theincubator. These results indicate that when women are tested for thepresence of Ureaplasma urealyticum closer to the actual date of deliveryusing the devices and methods of the invention, false positives can beeliminated and false negatives identified. This allows for theadministration of antibiotics to individuals who would otherwise notreceive treatment due to false negatives and avoid excess treatment toindividuals who otherwise show false positives or otherwise resolve anUreaplasma urealyticum infection prior to delivery.

Example 3

FIGS. 2A-D depict views of another embodiment of an incubator 200.Preferably, incubator 200 is a cylinder, however incubator 200 can haveanother shape, such as a cube, a pyramid, or a sphere. Incubator 200 canbe made of plastic, metal, glass, or another manmade or naturallyoccurring material. Preferably, the material is non-reactive to anyfluids contained within incubator 200. Preferably, incubator 200 has abody 205 and a lid 210. Body 205 preferably has flat bottom surface 215so that incubator 200 can be placed upright on a table or other surface.Lid 210 preferably can be secured within body 205. Preferably, lid 210is screwed into body 205, however lid 210 can be snapped into body 205,friction fitted into body 205 or secured in another method. In apreferred embodiment lid 210 can be secured to and removed from body 205multiple times. In other embodiments, lid 210 can only be secured tobody 205 once and then is permanently fixed to body 205.

Preferably a threaded insert 218 is fixed within body 205. Threadedinsert 218 is preferably coupled to body 205 with adhesive, howeverother fasteners can be used. For example, threaded insert 218 can becoupled to body 205 with a threaded engagement, friction, cotter rings,or other fastening devices. Preferably, a threaded portion of lid 210engages a threaded portion of threaded insert 218. Once engaged,incubator 200 is preferably air and/or water tight. Preferably, no gasesor liquids can enter or escape from incubator 200 once it is closed.Preferably, incubator 200 is hermetically sealed. In order to achieveproper sealing, washers, gels, or other sealants may be placed betweenand/or around threaded insert 218 and lid 210.

Preferably, a swab 220 is integrated into lid 210. Swab 220 ispreferably comprised of a rod having a first end attached to lid 210 anda second end attached to a sample obtaining device. Preferably, thesample obtaining device is cotton, another fabric, an adhesive, amagnet, a grabber, or another device capable of maintaining contact witha sample. Preferably, the rod is solid. The rod may be flexible orin-flexible. Preferably, incubator 200 has a multi-chamber core 225, aportion of which swab 220 can be inserted into. Preferably the upperchamber 225 of core 225 is an open space into which swab 220 can beinserted without encountering any fluids. Prior to use, swab 220 may bestore in the upper chamber 225 to prevent contamination of swab 220. Insuch embodiments, lid 210 may have a pre-use and post-use engagementsetting. For example, pre-use or prior to obtaining a sample, lid 210may only partially be coupled to body 205 and post-use or afterobtaining a sample, lid 210 may fully engage body 205.

Preferably, incubator 200 also has a middle chamber 230. Middle chamber230 preferably contains the culture medium, sample preserver, or otherfluid. Preferably middle chamber 230 is separated from upper chamber 225by a penetrable membrane 235. Preferably, penetrable membrane 235 keepsthe culture medium from escaping into the upper chamber prior to swab220 coming into contact with the culture medium. For example, as swab220 (after obtaining the sample) is inserted into core, the tip of swab220 is forced through penetrable membrane 235 so that the culture mediumis allowed to come into contact with the sample. Penetrable membrane 235may rip, be pushed out of the way, dissolve, open, retract, or otherwiseallow swab 220 into middle chamber 230. Middle chamber 230 may berefillable or be for onetime use. Additionally, if middle chamber 230 isrefillable, penetrable membrane 235 may be resettable or replaceable.Furthermore, there may be multiple middle chambers 230 each filled withsimilar or different fluids. For example, a first middle chamber may befilled with a first substance and a second middle chamber may be filledwith a second substance that when combined produce a chemical reactionthat is necessary in analyzing the sample.

Preferably, incubator 200 also has a lower chamber 240. Preferably,lower chamber 240 contains conditioning electronics 245. Preferably,lower chamber is protected from ingress of fluids from either upperchamber 225 or middle chamber 235 by seal 260. Lower chamber 240 maycontain a battery 250 or other power source, an activation switch, and afluid agitation device. For example, the fluid agitation device may be avibrating device, a pump, a propeller, or another device capable ofmoving fluids. In the case of a pump or a propeller, preferably aportion of the device is in contact with the fluids and a portion ismaintained as separate from the fluids. The fluid agitation device maywork continuously or intermittently. The incubator may additionallyinclude a micro-fluidic device. The micro-fluidic device may allow forthe inclusion of a lateral flow assay/device to be incorporated into theincubator for testing the sample when incubation is complete with orwithout an incorporated optical reader.

In other embodiments the fluid agitation device may be replaced oraccompanied by another device. For example, the incubator 200 mayinclude a heating or cooling device, drying device, a wetting device, anaerating, or another fluid conditioning device. Preferably, theelectronics only activate upon the swab 220 entering the middle chamber230. For example, as swab 220 is forced into the middle chamber 230, theswab contacts a bottom surface of middle chamber 230 which engages theswitch 255 within lower chamber 240 and activates the vibration device.Switch may also be a pressure, volume, optical or electronic trigger.Preferably, the battery is replaceable for multiple uses, howeverincubator 200 may be a onetime use device. Incubator 200 may be astandalone device or may be used in conjunction with a heating elementand/or processor as described herein.

Example 4

FIG. 3 depicts another example of an incubator 300. Incubator 300 issimilar to incubator 200, except the lid 310 of incubator 300 is astopper. Preferably lid 310 is friction fitted into an insert 318 thatis coupled to the body 305 of incubator 300. Insert 318 preferably ismade of a substance that increases the friction between lid 310 and body305. For example, insert 320 may be rubber, a knurled surface, adhesive,or another material with a high coefficient of friction.

Example 5

FIG. 4 depicts another example of an incubator 400. Incubator 400 issimilar to incubator 200, except incubator 400 includes a ball seal 490coupled to swab 420. Preferably, ball seal 490 provides a secondary sealto penetrable membrane 435. For example, after swab 420 piercespenetrable membrane 435, ball seal 490 engages the hole in penetrablemembrane 435 to limit the fluid from exiting the middle chamber.Additionally, ball seal 490 may provide a limit to how far into themiddle chamber swab 420 can extend. Ball seal 490 is preferably made ofrubber, but other materials can be used.

Example 6

FIG. 5 depicts another example of an incubator 500. Incubator 500 issimilar to incubator 200, except the rod of swab 520 is tapered.Preferably, the tapered rod provides a secondary seal to penetrablemembrane 535. For example, after swab 520 pierces penetrable membrane535, the tapered rod engages the hole in penetrable membrane 535 tolimit the fluid from exiting the middle chamber. Additionally, thetapered rod may provide a limit to how far into the middle chamber swab520 can extend. The tapered rod is preferably made of rubber, but othermaterials can be used.

Example 7

FIG. 6 depicts another example of an incubator 600. Incubator 600combines the tapered rod of incubator 500 with the ball seal ofincubator 400. In incubator 600, ball seal 690 replaces the penetrablemembrane of incubator 200. For example, ball seal 690 preferablycontains the fluid in the middle chamber until swab 620 forces ball seal690 into the middle chamber or aside, at which point the fluid withinthe middle chamber can come into contact with the sample. Then, thetapered rod engages the hole left by ball seal 690 or with ball seal 690to limit the fluid from exiting the middle chamber. Additionally, thetapered rod may provide a limit to how far into the middle chamber swab620 can extend. The tapered rod and ball seal 690 are preferably made ofrubber, but other materials can be used.

Example 8

FIGS. 7A and 7B depict an exterior and cross-sectional views of anotherembodiment of an incubator 700. Preferably, incubator 700 has a teardropshape, however incubator 700 can have another shape, such as a cube, apyramid, a cylinder, or a sphere. Incubator 700 can be made of plastic,metal, glass, or another manmade or naturally occurring material.Preferably, the material is non-reactive to any fluids contained withinincubator 700. Preferably, incubator 700 has a body 705 and a sampleassembly 710. Sample assembly 710 preferably can be secured within body705. Preferably, body 705 surrounds sample assembly 710 however sampleassembly 710 can be screwed into body 705, snapped into body 705,friction fitted into body 705 or secured in another method. In apreferred embodiment sample assembly 710 can be secured to and removedfrom body 705 multiple times. In other embodiments, sample assembly 710can only be secured to body 705 once and then is permanently fixed tobody 705.

Sample assembly 710 is preferably air and/or water tight. Preferably, nogases or liquids can enter or escape from sample assembly 710 once it issecured. Sample assembly 710 is hermetically sealed. In order to achieveproper sealing, washers, gels, or other sealants be positioned withinsample assembly 710.

FIGS. 8A and 8B depict an exterior and cross-sectional views of anembodiment of sample assembly 710. Sample assembly preferably comprisesa lid 718, a tube 720 containing a swab 722, and an ampule 725. Swab 722is preferably removable from tube 720 for obtaining a biological sample.Preferably, swab 722 is cotton, another fabric, an adhesive, a magnet, agrabber, or another device capable of maintaining contact with a sample.Preferably, swab 722 is coupled to lid 718 by a rod 732. The rod 732 maybe flexible or in-flexible. Prior to use, swab 722 may be stored in thetube 720 to prevent contamination of swab 722. In such embodiments, lid718 may have a pre-use and post-use engagement setting. For example,pre-use or prior to obtaining a sample, lid 718 be in a samplecollecting position (see FIGS. 9A-C) and after obtaining a sample, lid718 may be forced into a sample incubating position (see FIGS. 10A-C).Preferably, in the sample incubating position, swab 722 is forced intoampule 725 so that the biological sample may come into contact with amaterial contained within ampule 725. For example, lid 718 may becomprised of a fixed portion 740 and a rotating portion 745. Byunscrewing rotating portion 745, swab 722 may be removed from sampleassembly 710. After collecting the sample, rotating portion 745 may bescrewed back into fixed portion 740 past the sample collecting positioninto the sample incubating position.

Ampule 725 may have a penetrable membrane 735. Preferably, penetrablemembrane 735 keeps the culture medium from escaping into the tube 720prior to swab 722 coming into contact with the culture medium. Forexample, as swab 722 (after obtaining the sample) is inserted back intotube 720, the tip of swab 722 is forced through penetrable membrane 735so that the culture medium is allowed to come into contact with thesample. Penetrable membrane 735 may rip, be pushed out of the way,dissolve, open, retract, or otherwise allow swab 722 into ampule 725.Ampule 725 may be refillable or be for onetime use. Additionally, ifampule 725 is refillable, penetrable membrane 735 may be resettable orreplaceable. Furthermore, there may be multiple ampules 725 each filledwith similar or different fluids. For example, a first ampule may befilled with a first substance and a second ampule may be filled with asecond substance that when combined produce a chemical reaction that isnecessary in analyzing the sample.

Preferably, sample assembly 710 also has a conditioning element 730.Preferably, conditioning element 730 is protected from ingress of fluidsand contains a battery 750. Preferably, conditioning element 730 is aheating or cooling device, drying device, a wetting device, an aerating,a fluid agitation device, or a combination thereof. For example, thefluid agitation device may be a vibrating device, a pump, a propeller,or another device capable of moving fluids. In the case of a pump or apropeller, preferably a portion of the device is in contact with thefluids and a portion is maintained as separate from the fluids. Thefluid agitation device may work continuously or intermittently. Theincubator may additionally include a micro-fluidic device. Themicro-fluidic device may allow for the inclusion of a lateral flowassay/device to be incorporated into the incubator for testing thesample when incubation is complete with or without an incorporatedoptical reader.

Preferably, conditioning element 730 only activate upon the swab 722entering the ampule 725. For example, as swab 722 is forced into ampule725, the swab contacts a bottom surface of ampule 725 which engages aswitch 733 of conditioning element 730 and activates device. The switchmay also be a pressure sensor, a volume sensor, an optical readeradapted to detect the presence of the swab or sample, or an electronictrigger. Preferably, the battery is replaceable for multiple uses,however incubator 700 may be a onetime use device. Incubator 700 may bea standalone device or may be used in conjunction with an externalheating element and/or processor as described herein. Incubator 700 mayhave one or more lights 755 or indicators to indicate the current statusof the incubator.

Other embodiments and uses of the invention will be apparent to thoseskilled in the art from consideration of the specification and practiceof the invention disclosed herein. All references cited herein,including all publications, and all U.S. and foreign patents and patentapplications are specifically and entirely incorporated by reference.The term comprising, where ever used, is intended to include the termsconsisting and consisting essentially of. Furthermore, the termscomprising, including, and containing are not intended to be limiting.It is intended that the specification and examples be consideredexemplary only with the true scope and spirit of the invention indicatedby the following claims.

1. A disposable and/or reusable kit for detection of a microorganism orgroup of microorganisms in a biological sample comprising: a culturedevice comprising an incubator and an environmental chamber into whichis placed the incubator or the incubator is attached; culture mediumcontained within the incubator that promotes the proliferation orstabilization of the microorganism or group of microorganisms; and acollection tool for obtaining the biological sample and directingdelivery of the biological sample to the incubator.
 2. The culturedevice of claim 1, wherein the collection tool is a flocked swab.
 3. Theculture device of claim 1, wherein the culture medium comprises one ormore ingredients which promote the proliferation or stabilization of themicroorganism or group of microorganisms.
 4. The culture device of claim1, wherein the culture medium comprises ingredients that inhibitproliferation or stabilization of one or more microorganisms that arenot the microorganism or group of microorganisms to be detected.
 5. Theculture device of claim 1, wherein the environmental chamber containsone or more devices that control the environment of the incubator. 6.The culture device of claim 5, wherein the one or more devices comprisea heating element, a cooling element, a pH control element, a humiditycontrol element, an oxygen control element, a carbon dioxide controlelement, a vibrator, or a light control element.
 7. The culture deviceof claim 5, wherein the environmental chamber contains a USB port thatconnects the one or more devices to an external processer containingsoftware that controls the operation of the one or more elements, or theenvironmental chamber contains a microprocessor that contains softwareto control the one or more environmental control elements.
 8. Theculture device of claim 1, which is comprised of plastic.
 9. The culturedevice of claim 1, further comprising a micro-fluidic device, whereinthe micro-fluidic device allows for inclusion of a lateral flow assay ordevice incorporated into the incubator for testing the biological sampleupon completion of incubation with or without an optical reader to reador report a result.
 10. A method of detecting a microorganism or groupof microorganisms comprising: obtaining a biological sample with orwithout a collection tool; placing the biological sample into anincubator containing culture medium for the proliferation and orstabilization of the microorganism; sealing the incubator closed;placing the closed incubator within or attached to an environmentalchamber; allowing the microorganism or group of microorganisms toproliferate and or stabilize in the incubator for a period of time; andassessing proliferation and or stabilization of the microorganism orgroup of microorganisms to determine the presence or absence of themicroorganism or group of microorganisms in the biological sample. 11.The method of claim 10, wherein the biological sample is self-obtained.12. The method of claim 10, wherein the environmental chamber containsone or more environmental control elements.
 13. The method of claim 12,wherein the one or more environmental control elements comprise aheating element, a cooling element, a pH control element, a humiditycontrol element, an oxygen control element, a carbon dioxide controlelement, a vibrator, or a light control element.
 14. The method of claim12, wherein the environmental chamber contains a USB port that connectsthe one or more environmental control elements to an external processercontaining software that controls the operation of the one or moreenvironmental control elements and/or the environmental chamber containsa microprocessor that contains software to control the one or moreenvironmental control elements.
 15. The method of claim 10, furtherdetermining a quantitative or relative concentration of themicroorganism or group of microorganisms.
 16. The method of claim 10,wherein the period of time is from 1 hour to 7 days.
 17. The method ofclaim 10, wherein assessing comprising removing a sample from inside theincubator and determining the presence or absence of the microorganism.18. The method of claim 10, wherein assessing comprising performing avisual or chemical assessment, immunoassay, lateral flow assay, enzymelinked immunoassay, an immunochemistry assay, a polymerase chainreaction, a latex agglutination, other microbiologic assay or acombination thereof.
 19. The method of claim 10, wherein assessingcomprising insertion of a device to perform an analysis.
 20. The methodof claim 19, wherein the analysis comprises a visual analysis, achemical analysis, an immunoassay, a lateral flow assay, an enzymelinked immunoassay, an immunochemistry assay, a polymerase chainreaction, a latex agglutination, other microbiologic assay or acombination thereof.
 21. The method of claim 20, wherein the analysis isa visual analysis and the method further comprises determining at leastone of turbidity and color change with an optical reader.
 22. The methodof claim 10, further comprising transmitting the assessmentelectronically to a physician, health care worker, a professional, anexpert, a patient or another individual, or to a patient's medical orhealth care record.
 23. The method of claim 22, wherein the transmittingis accomplished by a WiFi.
 24. An incubator, comprising: a base; a lidadapted to be coupled to the base; a sample gathering device coupled tothe lid; a multi-chamber cavity within the base; and a seal adapted toprevent fluid from escaping a first chamber of the multi-chamber cavityand entering a second chamber of the multi-chamber cavity.
 25. Theincubator of claim 24, wherein the sample gathering device is a flockedswab.
 26. The incubator of claim 25, wherein the flocked swab is coupledto the lid by a rod.
 27. The incubator of claim 24, further comprising asample conditioning device.
 28. The incubator of claim 27, wherein thesample conditioning device is one of a fluid agitator, a heating device,a cooling device, a moisture removal device, a moisture adding device, apH control element, a humidity control element, an oxygen controlelement, a carbon dioxide control element, or a light control element.29. The incubator of claim 28, wherein the sample conditioning device ishoused in a third chamber of the multi-chamber cavity and the thirdchamber is sealed from the first and second chambers.
 30. The incubatorof claim 28, further comprising a switch adapted to activate the sampleconditioning device.
 31. The incubator of claim 24, wherein the seal isa penetrable membrane adapted to be pierced by the sample gatheringdevice.
 32. The incubator of claim 24, wherein the base and the lid aremaintained in a first position prior to sample gathering and aremaintained in a second position after sample gathering.
 33. Theincubator of claim 24, wherein in the first position the swab ismaintained outside the first chamber and in the second position the swabis maintained within the first chamber.
 34. A sample evaluation system,comprising: an incubator comprising: a base; a lid adapted to be coupledto the base; a sample gathering device coupled to the lid; amulti-chamber cavity within the base; and a seal adapted to preventfluid from escaping a first chamber of the multi-chamber cavity andentering a second chamber of the multi-chamber cavity; and a sampleconditioning fluid housed within the first chamber.
 35. The system ofclaim 34, wherein the sample gathering device is a flocked swab.
 36. Thesystem of claim 35, wherein the flocked swab is coupled to the lid by arod.
 37. The system of claim 34, the incubator further comprising asample conditioning device.
 38. The system of claim 37, wherein thesample conditioning device is one of a fluid agitator, a heating device,a cooling device, a moisture removal device, a moisture adding device, apH control element, a humidity control element, an oxygen controlelement, a carbon dioxide control element, or a light control element.39. The system of claim 37, wherein the sample conditioning device ishoused in a third chamber of the multi-chamber cavity and the thirdchamber is sealed from the first and second chambers.
 40. The system ofclaim 37, the incubator further comprising a switch adapted to activatethe sample conditioning device.
 41. The system of claim 34, wherein theseal is a penetrable membrane adapted to be pierced by the samplegathering device.
 42. The system of claim 34, wherein the base and thelid are maintained in a first position prior to sample gathering and aremaintained in a second position after sample gathering.
 43. The systemof claim 34, wherein in the first position the swab is maintainedoutside the first chamber and in the second position the swab ismaintained within the first chamber so that the sample comes intocontact with the sample conditioning fluid.
 44. The system of claim 34,wherein the sample is a microorganism or group of microorganisms and thesample conditioning fluid is a culture medium that promotes theproliferation or stabilization of the microorganism or group ofmicroorganisms.
 45. An incubator, comprising: a base; and a sampleassembly contained within the base, the sample assembly comprising: alid; a sample gathering device coupled to the lid; and an ampule;wherein the sample assembly is positionable between a sample gatheringposition and a sample incubating position.
 46. The incubator of claim45, wherein the sample gathering device is a flocked swab.
 47. Theincubator of claim 46, wherein the flocked swab is coupled to the lid bya rod.
 48. The incubator of claim 45, further comprising a sampleconditioning device.
 49. The incubator of claim 48, wherein the sampleconditioning device is one of a fluid agitator, a heating device, acooling device, a moisture removal device, a moisture adding device, apH control element, a humidity control element, an oxygen controlelement, a carbon dioxide control element, or a light control element.50. The incubator of claim 45, wherein the sample gathering device ismaintained outside the ampule in the sample gathering position and isforced into the ampule in the sample incubating position.
 51. Theincubator of claim 50, further comprising a penetrable membraneseparating contents of the ampule from the sample gathering device,wherein the penetrable membrane adapted to be pierced by the samplegathering device.
 52. The incubator of claim 45, further comprising aswitch adapted to activate the sample conditioning device.
 53. Theincubator of claim 45, wherein the incubator is adapted to collect,process, transport, and stabilize a sample for use in biomarkerdeterminations or cancer tissue testing.
 54. The incubator of claim 45,wherein the incubator is adapted to collect, incubate, and transport abiological sample.
 55. A sample evaluation system, comprising: anincubator comprising: a base; and a sample assembly contained within thebase, the sample assembly comprising: a lid; a sample gathering devicecoupled to the lid; and an ampule; wherein the sample assembly ispositionable between a sample gathering position and a sample incubatingposition; and a sample conditioning medium housed within the ampule. 56.The system of claim 55, wherein the sample gathering device is a flockedswab.
 57. The system of claim 55, wherein the flocked swab is coupled tothe lid by a rod.
 58. The system of claim 55, the incubator furthercomprising a sample conditioning device.
 59. The system of claim 58,wherein the sample conditioning device is one of a fluid agitator, aheating device, a cooling device, a moisture removal device, a moistureadding device, a pH control element, a humidity control element, anoxygen control element, a carbon dioxide control element, or a lightcontrol element.
 60. The system of claim 55, wherein the samplegathering device is maintained outside the ampule in the samplegathering position and is forced into the ampule in the sampleincubating position.
 61. The system of claim 60, further comprising apenetrable membrane separating contents of the ampule from the samplegathering device, wherein the penetrable membrane adapted to be piercedby the sample gathering device.
 62. The system of claim 55, furthercomprising a switch adapted to activate the sample conditioning device.63. The system of claim 55, wherein the sample is a microorganism orgroup of microorganisms and the sample conditioning fluid is a culturemedium that promotes the proliferation or stabilization of themicroorganism or group of microorganisms.
 64. The system of claim 55,wherein the incubator is adapted to collect, process, transport, andstabilize the sample for use in biomarker determinations or cancertissue testing.